The Danish medicines agency, Lægemiddelstyrelsen, maintained its clean slate on case handling times for clinical trial applications in the year to August 2006. The agency dealt with a total of 208 applications during the first eight months of the year, all of which were completed within the time limit of 30 days agreed with the pharmaceutical industry.
As the agency points out, the standard time limit for approving clinical trials in the European Union is 60 days, corresponding to roughly 45 working days. Under the EU’s Clinical Trials Directive, 2001/EC/EC, the 60-day ceiling applies both to regulatory clearance and ethics committee approval, although member states have leeway to apply a shorter time period.
The Danish agency’s adherence to the 30-day limit continues a pattern seen over the whole of 2005. The picture is somewhat misleading, though, as Lægemiddelstyrelsen starts the clock only when it receives a ‘valid’ application – i.e, one that does prompt any comments from the agency. In the first seven months of 2006, the percentage of valid applications for clinical trials ranged from 72% (13 out of 18) in August to a low of 32% (10 out of 31) in May. By Peter Mansell
